As of right now, officials at the Food and Drug Administration (FDA) have mandated that all ranitidine medications, brand name Zantac, be taken off store shelves immediately. This order was tied to concerns that the medication may contain a cancer-causing chemical that has been detected in certain types of blood pressure medications. In January a voluntary recall was implemented, but FDA officials note that there is evidence the impurity in the cancer-causing chemicals in Zantac may increase as time goes on.
FDA officials have issued the mandatory recall due to the fact that they have “determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.” FDA officials have also sent letters to drug manufacturers in order to request that they “withdraw their products from the market.” They are also advising consumers who are taking OTC ranitidine as part of their health care to discontinue taking any tablets or liquid they currently have, to dispose of them properly, and to not purchase more; for those who are looking to continue treating their condition, they need to start thinking about purchasing other approved OTC products. The history of this recall goes to October, where pharmaceutical company Sanofi announced that it was undertaking a voluntary recall of Zantac due to the concerns about the potential cancer-causing chemical.
A number of drug stores last year stopped selling the drug, and CVS and Walgreens now no longer sell Zantac and other ranitidine medications. CVS offered customers who had recently purchased Zantac or another ranitidine drug a full refund, and the chain continues to sell other over-the-counter (OTC) heartburn medications such as Pepcid and Tagamet that don’t contain ranitidine. In September, the FDA reported that small traces of NDMA were detected in several brand-name and generic heartburn medications. This has a significant impact on many people who regularly use ranitidine medications to prevent and treat heartburn, ulcers, and gastroesophageal reflux disease (GERD). Whether or not the low levels found in the ranitidine medicines create a health risk was investigated by the FDA. Even though NDMA may result in harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests are barely over amounts that you may expect to find in common foods.
NDMA is an environmental contaminant that can be found in water along with meat, dairy, and vegetables, and is classified as a B2 carcinogen, which means that it is most likely a human carcinogen. The World Health Organization put out that exposure to high amounts of NDMA is thought to result in gastric or colorectal cancer, and is extremely toxic to the liver. Even tiny amounts may be directly connected to liver cancer. To put things in perspective, this chemical
was once used to make rocket fuel. Today, this chemical is only put to use for research purposes in the United States, as the Environmental Protection Agency states. It is also the byproduct of several manufacturing processes at industrial sites, including tanneries, pesticide manufacturing plants, and rubber and tire manufacturers.
If you have been taking Zantac and are pursuing legal action, call Madalon Law for a consultation today.